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Pass on § 3, 7, 8, and 9 of these instructions to the Patient.
1 INCLUDED ITEMS
Part Description Part Number Included/Sold Separately
ShockWave Foot F20-S3-XXAYY-ZZ Included
Foot Shell
FTC-3F-1XXX4-RX
FTC-2F-1XXX4-SX
Sold Separately
Spectra™ Sock SO-NPS-XXXXX-00 Included
Heel Bumper Kit (Sizes 23-25 cm) KIT-00-11463-00
Appropriate Kit Included
Heel Bumper Kit (Sizes 26-28 cm) KIT-00-11464-00
Heel Bumper Kit (Sizes 29-30 cm) KIT-00-11465-00
2 DESCRIPTION AND PROPERTIES
A. Description
The ShockWave is an energy storing prosthetic foot with J-shaped keel, heel component, and a vertical loading pylon that
provides controlled motion for shock absorption and axial rotation.
B. Properties
Weight 2.20 lbs / 998g
Build Height
23
–
25cm
6.9” / 175mm
26
–
28cm
7.3” / 186mm
29
–
30cm
7.8” / 198mm
Heel Rise 3⁄8”/ 10mm
Weight based on a size 26cm, Cat 4 Foot Module with Foot Shell and Spectra Sock.
Build height based on 23cm, 26cm or 29cm, Cat 4 Foot Module with Foot Shell, Spectra
Sock, and 10mm heel rise.
This device has undergone a two-million-cycle test, in accordance with standard ISO 10328 (at a P7 load level for 147kg [325
lbs.]), which corresponds to a service life of 2 to 3 years, depending on the patient’s activity level.
Category Selection Guide
Weight
lb 110-115 116-130 131-150 151-170 171-195 196-220 221-255 256-285 286-325
kg 44-52 53-59 60-68 69-77 78-88 89-100 101-116 117-130 131-147
Activity
Level
Low 1 1 2 3 4 5 6 7 8
Moderate 1 2 3 4 5 6 7 8 -
High 2 3 4 5 6 7 8 - -
3 INTENDED USE/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists) who will train the patient in its use. The prescription is
made by a doctor together with the prosthetist, who assess the patient's ability to use it.
This device is for SINGLE PATIENT use. It should not be reused on another patient.
This device is intended for use by prosthesis wearers who would benefit from the safety, stability,
and improved gait dynamics of the ShockWave. Users should meet the requirements of a
Medicare functional level of K3 or higher.
This device is indicated for use as a component in a prosthetic leg for individuals with unilateral
or bilateral lower-limb amputations or limb deficiencies, including:
• Transtibial amputation
• Transfemoral amputation
• Knee disarticulation amputation
• Hip disarticulation amputation
• Congenital, lower-limb deficiencies
Maximum weight (load carrying included): See above table
4 CLINICAL BENEFITS
The device provides clinical benefits and performance including:
• Ability to ambulate on variable terrain
• Shock absorption
• Axial rotation
• Reduced socket forces and increased comfort
Freedom ShockWave™ by PROTEOR
Prosthetist Instructions for use
Read before use
IFU-01-097
Rev C
2021-10
2
0
2
1